BEUDAMED
    FDA Adverse Event Other Summary report: N

    AEROSET ANALYZER

    MDR report key: 734366 · Received June 29, 2006

    Report

    Report Number
    1628664-2006-00063
    Event Type
    Other
    Date Received
    June 29, 2006
    Date of Event
    June 12, 2006
    Report Date
    June 13, 2006
    Manufacturer
    ABBOTT LABORATORIES, INC
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ABBOTT TECHNICAL EXECUTIVE (TE) ARRIVED AT THE CUSTOMER SITE AND INITIALLY REPLACED THE ACID WASH VALVE BUT ALSO DISCOVERED A LEAKING CUVETTE WASHER WITH THE MIXING ASSEMBLY OUT OF ALIGNMENT. THE TE RE-TRAINED THE ROBOTICS AND REPLACED THE WASH SOLUTIONS PUMPS VALVE. SUBSEQUENT INSTRUMENT OPERATIONS AND TEST RESULTS WERE ACCEPTABLE. THIS ISSUE IS ADDRESSED IN THE AEROSET SYSTEM OPERATIONS MANUAL (LN:09D06-05) UNDER THE FOLLOWING SECTIONS: SECTION 9, SERVICE AND MAINTENANCE WEEKLY MAINTENANCE PROCEDURES REQUIRE THAT OPERATORS PERFORM THE FOLLOWING: CLEAN THE MIXERS TO PREVENT PROTEIN BUILD-UP, DURING WHICH THE MIXERS ARE ADJUSTED AND HOMED. MONTHLY MAINTENANCE PROCEDURES REQUIRE THAT OPERATORS PERFORM THE FOLLOWING ON A MONTHLY BASIS: CLEAN CUVETTE WASHER NOZZLES TO ENSURE OPTIMAL OPERATION OF THE CUVETTE WASHER ASSEMBLY, WHICH REMOVES SAMPLE AND REAGENT MIXTURES, WASHES, RINSES, AND DRIES CUVETTES. ANNUAL MAINTENANCE PROCEDURES REQUIRE THAT OPERATORS PERFORM THE FOLLOWING: PERFORM CHECK VALVE REPLACEMENT (WASH SOLUTION AND ICT REFERENCE SOLUTION PUMP 1 ML SYRINGES) YEARLY AND ANY TIME THE VALVES FAIL. SECTION 10, TROUBLESHOOTING AND DIAGNOSTICS- RESULT ERROR CODE A#0: NONE OF THE PHOTOMETRIC READS DURING THE MAIN OF FLEX READ TIME HAD MEASURED ABSORBANCES WITHIN THE DEFINED ABSORBANCE LIMIT. PROBABLE CAUSES INCLUDE- WATER OR WASH SOLUTIONS ARE NOT ASPIRATED ON DISPENSED CORRECTLY INTO REACTION CUVETTES, CUVETTE WASHER IS NOT FUNCTIONING PROPERLY, AND R2 MIXER NOT FUNCTIONING PROPERLY. THE CORRESPONDING CORRECTIVE ACTIONS ARE: PERFORM THE CLEAN CUVETTE WASHER NOZZLES PROCEDURE, AND CONTACT YOUR ABBOTT REPRESENTATIVE. OBSERVED PROBLEMS LISTS; SCHEDULE MAINENANCE IS DUE, MIXER MALFUNCTION, AND CUVETTE WASHER MALFUNCTION AS PROBABLE CAUSES OF "RESULTS ARE ERRATIC, PRECISION IS POOR." THE CORRESPONDING CORRECTIVE ACTIONS INCLUDE PERFORMING THE SCHEDULED MAINTENANCE, AND CONTACTING AN ABBOTT REP. THE AEROSET SERVICE AND SUPPORT MANUAL (89000-104) ALSO ADDRESSES THIS ISSUE IN SECTION 2, TROUBLESHOOTING REFERENCE, INCLUDES: SCHEDULE MAINTENANCE IS DUE, MIXER MALFUNCTION, CUVETTE WASHER MALFUNCTION, AND DEFECTIVE SYRINGE VALVE AS PROBABLE CAUSES OF ERRATIC RESULTS, POOR PRECISION. SECTION 6, PLANNED MAINTENANCE(PM), REQUIRES THAT THE ACID WASH VALVE BE REPLACED DURING PM3. CUVETTE WASHER NOZZLES ARE ALSO CLEANED DURING PM1, PM2, AND PM3. THE INVESTIGATION DEMONSTRATED THAT THE AEROSET ANALYZER IS PERFORMING WITHIN ITS INTENDED USE, LABEL CLAIMS AND SPECIFICATIONS. NO DEFICIENCY RELATED TO THE PERFORMANCE OF THE DEVICE WAS IDENTIFIED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ERRATIC RESULTS ARE BEING GENERATED BY THE AEROSET ANALYZER. AS AN EXAMPLE, THE CUSTOMER STATES THAT AN INITIAL CALCIUM RESULT OF 19.23 MG/DL RETESTED AT A VALUE OF 9.2 MG/DL. NO SUSPECT RESULTS HAVE BEEN REPORTED FROM THE LAB. THERE IS NO IMPACT TO PT MANAGEMENT REPORTED. THE CUSTOMER HAS REQUESTED A SERVICE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEROSET ANALYZER AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT LABORATORIES, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN CC CALCIUM ASSAY LIST#7D61-20, LOT:UNK